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Pancreatic NeoplasmsNCT02909530

Comparison Between Olympus EZ Shot 3Plus 19G and EZ Shot 2 19G in EUS-guided FNB of Solid Pancreatic Masses

A study testing EUS-FNB with EZ Shot 3Plus first and EUS-FNB with EZ Shot 2 19G first in people with Pancreatic Neoplasms, run by University of Ulm at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) is a valid and recommended technique for tissue diagnosis of pancreatic masses. However, the diagnostic yield is with a sensitivity of 64%-95% and an accuracy of 78%-94% still very low. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Neoplasms
What is being tested?
EUS-FNB with EZ Shot 3Plus first and EUS-FNB with EZ Shot 2 19G first
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
4 sitesGermany
Study dates
Sep 2016to Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • solid pancreatic mass and consecutive indication for EUS-FNB

Who cannot join

  • incapacity to give informed consent
  • Haemorrhagic disease, disorder of hemostasis and coagulation (PT <60%, PTT> 42 sec. and platelets <60000/µL)
  • oral anticoagulants
  • dual antiplatelet therapy with thienopyridines (e.g. clopidogrel)
  • Pregnant or lactating

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Israelitisches Krankenhaus Hamburg

    Hamburg, 22297

  • Niel Stensen Kliniken Marienhospital Osnabrück

    Osnabrück, 49074

  • Klinikum Stuttgart, Katharinenhospital

    Stuttgart, 70174

  • University Ulm

    Ulm, 89081

Other trials in Germany

About this study

Official title: Comparison Between the Olympus EZ Shot 3Plus 19G and EZ Shot 2 19G in Endoscopic Ultrasound-guided Fine Needle Biopsy of Solid Pancreatic Masses

Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) is a valid and recommended technique for tissue diagnosis of pancreatic masses. However, the diagnostic yield is with a sensitivity of 64%-95% and an accuracy of 78%-94% still very low. The EUS-FNB of pancreatic masses is usually performed with a 22-gauge biopsy needle. The small diameter of the needle is usually responsible for the low yield of tissue samples for histopathological examination. The 19-gauge needles help to overcome the limitations of a 22-gauge needle by acquiring a larger amount of cellular material. Thus, performing EUS-FNB with a 19-gauge needle can maximize tissue acquisition and sample adequacy, which is important for appropriate diagnosis. Contrariwise, the technical success rate for sample retrieval in patients with pancreatic head lesions is significantly lower using the 19-gauge compared to the 22-gauge needle. This is attributable to the technical difficulty to push the needle out of the endoscope in the duodenum. Since about 60% of pancreatic cancers are located in the head region, it is therefore particularly important to improve technical success in these cases. The new 19-gauge biopsy needle "Olympus EZ Shot3 Plus" is more flexible than common biopsy needles such as "EZ Shot2" and should therefore provide improved access to regions like pancreatic head. The aim of this multicenter prospective randomized crossover study is to compare those two needles during EUS-FNB of solid pancreatic masses.

Therefore this study will enroll 40 patients in five German centers with solid pancreatic masses and consecutive indication for EUS-FNB. Both needles will be used in each patient following a predetermined random order.

Read more

Primary endpoint is the correct histological diagnosis of the mass assessed by each needle. Technical failure is regarded as a negative histological diagnosis.

Secondary endpoints include a comparison of technical failure using each needle, histological quality, duration of procedure and rate of adverse events.

Being tested
EUS-FNB with EZ Shot 3Plus first, EUS-FNB with EZ Shot 2 19G first
Keywords
Endoscopic ultrasound-guided fine needle biopsy, Olympus EZ Shot 3Plus, Olympus EZ Shot 2
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EUS-FNB with EZ Shot 3Plus firstDevice

    Both needles (EZ Shot 3Plus 19G and EZ Shot 2 19G) will be used for endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) in each patient following a predetermined random order which needle is used to pass through the tumor first.

  • EUS-FNB with EZ Shot 2 19G firstDevice

    Both needles (EZ Shot 3Plus 19G and EZ Shot 2 19G) will be used for endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) in each patient following a predetermined random order which needle is used to pass through the tumor first.

Study groups in NCT02909530
Study groupRoleWhat they receive
First pass EZ Shot 3Plus then EZ Shot 2Active comparatorOlympus EZ Shot 3Plus will be used to puncture the mass first (Intervention EUS-FNB with EZ Shot 3Plus first), then the 19G and EZ Shot 2 will be used to puncture the pancreatic mass.
Receives: Device: EUS-FNB with EZ Shot 3Plus first
First pass EZ Shot 2 then EZ Shot 3PlusActive comparatorOlympus EZ Shot 2 will be used to puncture the mass first (Intervention EUS-FNB with EZ Shot 2 19G first), then the EZ Shot 3Plus will be used to puncture the pancreatic mass.
Receives: Device: EUS-FNB with EZ Shot 2 19G first

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correct histological diagnosis of the mass assessed by each needle

    Correct histological diagnosis of the mass assessed by each needle compared to gold standard. Gold standard is primarily positive histology, followed by diagnosis made due to additional methods to assess for malignancy (ultrasound, CT, ERCP, surgically retrieved specimen).

    Measured: 6 months

Secondary outcomes (5)

  1. technical failure (inability to push the EUS-FNB needle out the endoscope to perform puncture)

    Number of failure to push the needle out of the endoscope to perform biopsy counted per needle type.

    Measured: Day one

  2. histological quality of the specimen retrieved (visual analog scale)

    Comparison of histological Quality using visual analog scale

    Measured: 24 months

  3. histological quality of the specimen retrieved (over all satisfaction)

    Comparison of histological Quality using over all satisfaction ("1"<"2", "1"="2", "1">"2")

    Measured: 24 months

  4. Duration of procedure

    time frame between Insertion and extraction of needle or failure to conduct FNB

    Measured: Day one

  5. Adverse events

    Acquisition of immediate adverse events related to the procedure or adverse events in the following 24 hours surveillance period or reported delayed adverse events (over 24 hours) related to the procedure

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionFeb 2018
  4. Study completionFeb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02909530
Sponsor's protocol ID
222/16
Status last verified
Feb 2019
First submitted
7 Sep 2016
Last updated
22 Feb 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Hann A, Epp S, Veits L, Rosien U, Siegel J, Moschler O, Bohle W, Meining A. Multicenter, randomized comparison of the diagnostic accuracy of 19-gauge stainless steel and nitinol-based needles for endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic masses. United European Gastroenterol J. 2020 Apr;8(3):314-320. doi: 10.1177/2050640619887580. Epub 2019 Nov 7.

    PubMed 32213013

Questions about this trial

What is this clinical trial studying?

A study testing EUS-FNB with EZ Shot 3Plus first and EUS-FNB with EZ Shot 2 19G first in people with Pancreatic Neoplasms, run by University of Ulm at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correct histological diagnosis of the mass assessed by each needle (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02909530, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.

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